Clinical Evaluation of NeoPlex4 Assay and NeoPlex System
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess the agreement of clinical performance between the proposed NeoPlex 4 assay and NeoPlex System and the comparator devices in clinical use in newborn screening programs for detection of T4, TSH, 17-OHP and IRT.
| Condition |
|---|
|
Adrenal Hyperplasia, Congenital Congenital Hypothyroidism Cystic Fibrosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Clinical Evaluation of the xMAP® NeoPlex4™ Assay for Detection of T4, TSH, 17-OHP and IRT Using the NeoPlex System |
| Enrollment: | 7462 |
| Study Start Date: | December 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
General Newborn Population-Prospective
Specimens prospectively collected in the course of routine newborn screening originating from hospitals, birthing centers, and/or clinics.
|
|
Newborn Specimens-Confirmed Positive
Banked confirmed positive specimens that were originally collected as part of the newborn screening program, but when found to screen positive for a disease, were followed up clinically to definitively diagnose the subject with the disease (CF, CAH or CH). Follow up results were reported to the sites by the treating clinicians.
|
Detailed Description:
The proposed (investigational) NeoPlex4 assay measures levels of thyroxine (T4), thyrotropin (hTSH), 17-alpha-OH-progesterone (17-OHP) and immunoreactive trypsinogen (IRT) from dried blood specimens (DBS) collected from neonates to screen for congenital hypothyroidism (CH), congenital adrenal hyperplasia (CAH) and cystic fibrosis (CF). The Clinical Evaluation of the xMAP® NeoPlex4™ Assay (NeoPlex4) for Detection of T4, TSH, 17-OHP and IRT using the NeoPlex System is a multi-center method concordance study on a combination of prospectively collected neonatal dried blood spots and pre-selected archived frozen dried blood spots that have been demonstrated to be positive for 17-OHP (CAH), IRT (CF), and T4 or TSH (CH). The study will be conducted at selected sites that routinely perform newborn screening testing in the United States.
Eligibility| Ages Eligible for Study: | up to 7 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Specimens will be derived from prospectively collected neonatal specimens and banked neonatal specimens originating from hospitals, birthing centers, and/or clinics. Newborn screening is currently performed on all neonates; there is no selection criterion for subjects.
Inclusion Criteria:
- The dried blood spot specimen was collected on an FDA-cleared collection paper that has not yet passed its expiration dating.
- Prospective specimens used in this study should only be those collected for the first time from a subject, or initial collection specimens.
Exclusion Criteria:
- Collected within 24 hours of birth.
- Specimens stored at ambient temperature for greater than 14 days prior to testing.
- The specimen DBS appears diluted.
- The specimen DBS shows evidence of clotting, caking, layering or serum rings.
- The DBS punched disks were punched too close to the edge of the blood spot or show printed markings.
- The specimen or collection card was contaminated with fecal material.
- Non-eluting blood spot due to deterioration of sample caused by exposure to heat and humidity.
Contacts and Locations| United States, New York | |
| New York State Department of Health | |
| Albany, New York, United States, 12201 | |
| United States, Tennessee | |
| Tennessee Department of Health | |
| Nashville, Tennessee, United States, 37243 | |
| United States, Utah | |
| Unified State Laboratories: Public Health | |
| Taylorsville, Utah, United States, 84129 | |
| Study Director: | Dennis Smith, PhD | Luminex Corporation |
More Information
No publications provided
| Responsible Party: | Luminex Molecular Diagnostics ( Luminex Corporation ) |
| ClinicalTrials.gov Identifier: | NCT01488721 History of Changes |
| Other Study ID Numbers: | CLD-0001 |
| Study First Received: | December 6, 2011 |
| Last Updated: | August 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Adrenal Hyperplasia, Congenital Adrenogenital Syndrome Adrenocortical Hyperfunction Congenital Hypothyroidism Cystic Fibrosis Fibrosis Hyperplasia Hypothyroidism Disorders of Sex Development Urogenital Abnormalities Congenital Abnormalities Genetic Diseases, Inborn Steroid Metabolism, Inborn Errors Metabolism, Inborn Errors Metabolic Diseases |
Adrenal Gland Diseases Endocrine System Diseases Gonadal Disorders Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Thyroid Diseases Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Infant, Newborn, Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013